FDA UDI
In Commercial Distribution
🇺🇸 United States
Orpyx SI Sensory Insoles
DI: 10185571000066
·
Model: OSIDDV1
·
Orpyx
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orpyx SI Sensory Insoles
- Primary DI
- 10185571000066
- Version / Model
- OSIDDV1
- Catalog Number
- 10185571000066
- Company Name
- Orpyx
- Labeler DUNS
- 250917031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-07
- Public Version
- 1
- Public Version Date
- 2025-02-17
- Public Version Status
- New
- Public Device Record Key
- cb027bc7-a13e-42e5-b8ce-a4c3bc94903a
Device Description
The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smartphone with the Orpyx Sensory Insole mobile application. The device provides the user with notification, and enables the transfer of data to enable remote patient monitoring. The following is included: Digital Display - Charging accessories - Instructions for use manual
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRN | Device, Warning, Overload, External Limb, Powered | Physical Medicine | 890.5575 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62169 | Wireless patient monitor/sensor reporting software, layperson-use | A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10185571000066 | GS1 |